This is a randomized, within-patient controlled study to compare the clinical performance of the ReCell Device with that of Split-thickness Meshed Skin Grafts for the treatment of second degree burns. The hypothesis to be supported are: 1) non-inferiority with the primary efficacy endpoint defined as recipient site wound closure at week 4 follow-up visit of the ReCell-treated area as compared to that of the STMSG-treated area, and 2)superiority in the healing of the ReCell donor site as compared to the STMSG donor site at week 1.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
101
The surgeon will be required to select two similar non-contiguous injury areas with both areas being at least 100cm2 and second degree depth/severity. One area will be treated using ReCell and the second using Split-thickness Skin Graft.
Arizona Burn Center at Maricopa Integrated Health Systems
Phoenix, Arizona, United States
University of California Davis Regional Burn Center
Sacramento, California, United States
The Burn Center at Washington Hospital Center
Washington D.C., District of Columbia, United States
Shands Burn Center at University of Florida
Gainesville, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Indiana University - Richard M. Fairbanks Burn Center at Wishard Memorial Hospital
Indianapolis, Indiana, United States
NC Jaycee Burn Center at University of NC at Chapel Hill
Chapel Hill, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
University of Tennessee Medical Center
Memphis, Tennessee, United States
USAISR
Fort Sam Houston, Texas, United States
...and 2 more locations
Incidence of RECELL-treated Area Closure Compared to Control at 4 Weeks (Non-inferiority)
Recipient site wound closure for both ReCell and STMSG will be defined as the presence of \>=95% epithelialization with contiguous layer of viable epithelium without the need for secondary surgical intervention. Factors considered during the assessment included color, presence of granulation tissue, and whether or not the entire wound is covered with a contiguous layer of viable epithelium. Using this definition, some small degree of punctate blistering was acceptable as long as the wound was \>=95% epithelialized.
Time frame: 4 weeks
Incidence of RECELL Donor Site Healing Compared to Control at 1 Week (Superiority)
Donor site healing will be considered as complete (100%) wound closure if the following criteria were met: an ability to separate the dressing from the wound bed with visible presence over the entirety of the wound of dry, opalescent-pink external surface representing the newly formed outer cornfield layer of the epidermis.
Time frame: 1 week
Percent of Epithelialization at Each Visit Through Week 16
The percent epithelialization of the RECELL and Control treated sites will be assessed using standardized planimetry/tracing procedures. The tracings were uploaded to a Central Reading Facility for calculation of percent epithelialization using a computerized measurement technique.
Time frame: Each visit through Week 16
Wound Closure at Week 2 (Based on Investigators Assessment)
The proportion of recipient sites achieving wound closure at Week 2 was evaluated using the Investigators assessment of wound healing.
Time frame: Week 2
Mean Pain and Appearance Scores at RECELL and Control Recipient Sites (Subject Assessment)
Subject assessment of pain at the RECELL and Control recipient sites was performed at all study follow-up visits up to Week 16. Subjects also assessed the satisfaction with the appearance of the treatment sites at the Week 16, 24, and 52 study follow-up visits. The subject assessments were performed using VAS (visual analogue scale) style questionnaires. Pain VAS 0-100 where 0=non-existent pain and 100=severe pain. Appearance VAS 0-100 where 0=terrible and 100=exceptional
Time frame: Pain (Weeks 1-16) and Appearance (Weeks 16-52)
Mean Pain and Appearance Scores at Donor Sites (Subject Assessment)
Subject assessment of pain at the RECELL and Control donor sites was performed at all study follow-up visits up to Week 16. Subjects also assessed the satisfaction with the appearance of the donor sites at the Week 16, 24, and 52 study follow-up visits. The subject assessments were performed using VAS (visual analogue scale) style questionnaires. Pain VAS 0-100 where 0=non-existent pain and 100=severe pain. Appearance VAS 0-100 where 0=terrible and 100=exceptional.
Time frame: Pain (Weeks 1-16) and Appearance (Weeks 16-52)
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